Search Results

Ask a specific question about this device

Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.

Drainage Bag

The provided document is a 510(k) clearance letter from the FDA for a Drainage Bag (K990428). This type of document is a regulatory approval and does not contain information about device acceptance criteria, performance studies, or AI performance metrics as requested in the prompt.

Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:

1. Confirming that the device is substantially equivalent to legally marketed predicate devices.
2. Outlining the regulatory requirements for marketing the device.
3. Stating the intended use of the device.

There is no data presented in this document about clinical studies, test sets, ground truth, or AI performance.

Ask a specific question about this device

The Manan™ D Bag is for nephrostomy, abcess and other drainage collection.

The Manan D Bag is a 600 ml drainage bag to be used for biliary, nephrostomy and other fluid drainage procedures. The bag has a twist close closure at the bottom for allowing the fluid to drain out. The bag is manufactured from either SP 2255, (an Ethylene Methyl Acrylate Copolymer film) or PVC. The catalog number will be DBAG 600 when Ethylene Methyl Acrylate Copolymer film is used, and DBAG 600V when PVC is used. The bag itself has a backing made from a non-woven polyester. This backing provides comfort for the patient. This backing will be optional on the product. A tube made from silicon is attached to the bag at one end and has a luer lock at the other for attaching to the drainage catheter. The preferred length of this tube is 30 ins. Other lengths between 24 and 42 ins. could possible be used in the future. An adjustable Velcro strap with some elasticity is supplied with the bag so it can be hung about the patient's waist, leg or shoulder.

This document is a 510(k) summary for the Manan™ D Bag, a medical device used for fluid drainage. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information from a study with acceptance criteria or device performance data.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a regulatory submission for premarket clearance, not a performance study report. Its purpose is to show that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison of design, materials, and intended use, rather than through extensive clinical or performance testing data as you've requested.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device